The Selection of Pregnancy for Patients After Tubal Ectopic Pregnancy Treatment

NCT05498558 | Unknown DMC

• 1 other identifier: ShanghaiFMIH2022-LSD
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of re-ectopic pregnancy in patients with tubal ectopic pregnancy increases significantly, which may be related to the condition of the fallopian tubes, such as tubal inflammation, tubal obstruction and other high-risk factors that may lead to tubal ectopic pregnancy; it is also associated with the treatment of the previous tubal ectopic pregnancy. Compared with salpingectomy, the treatment of preserving the fallopian tubes increased the incidence of re-ectopic pregnancy while increasing the pregnancy rate of the patient. For tubal-preserving patients, the most common option currently used is to recommend that monitoring ovulation during each menstrual cycle if they choose to conceive naturally rather than IVF. If ovulation occures on the healthy side of the ovary, it may be considered to try to conceive; Otherwise, contraception is recommended. However, there are uncertainties about this option. Based on this, we intend to conduct a multicenter clinical trial to verify the effectiveness of the ovulation preparation regimen on the healthy side of ovary.

Conditions

Tubal-preserving Treatment of Tubal Ectopic Pregnancy; Tubal Pregnancy; Pregnancy Preparation

Outcome Measures

Primary Outcomes (1)

• Rate of tubal pregnancy within12 months in both groups of patients.

  Tubal ectopic pregnancy refers to the implantation of embryo in the fallopian tubes.

  2023.10

Secondary Outcomes (1)

• Rates of pregnancy and miscarriage within 12 months in both groups of patients.

  2023.10

Study Arms (2)

Ovulation occurs on the healthy side

In tubal-presering patient who received treatment of tubal ectopic pregnancy,only when ovulation occurs on the healthy side of ovary,it may be considered to try to conceive; otherwise, contraception is recommended.

Other: No intervention.

Ovulation occurs on the either side

In tubal-presering patient who received treatment of tubal ectopic pregnancy,ovulation occurs on the either side of ovary,it may be considered to try to conceive.

Other: No intervention.

Interventions

No intervention. OTHER

No intervention.

Ovulation occurs on the either side; Ovulation occurs on the healthy side

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with fertility needs who received tubal-preserving treatment during prior tubal ectopic pregnant in Shanghai First Maternity and Infant Hospital, Shanghai Zhoupu Hospital, Shanghai Seventh People's Hospital.

You may qualify if:

• After tubal pregnancy treatment (including expectant therapy, medication, salpingotomy), the blood hCG value returns to normal;
• The patient has fertility requirements;
• The age of the patient is between 18-41 years old;
• Regular menstruation;
• There is no abnormality in the husband's semen examination;
• No history of sex hormone drugs in the 3 months prior to the examination;
• No underlying diseases such as heart, liver, kidneys and brain;
• No history of tuberculosis;
• Normal blood routine examination (WBC≥ 4\*109/L, HB≥100g/L, PLT≥100\*109/L);
• Normal liver and kidney function tests;
• Normal thyroid function;
• The patient can withstand and receive follicle monitoring during pregnancy;
• Negative for pregnancy test before treatment.

You may not qualify if:

• Cervical pregnancy, cesarean scar pregnancy, cornual pregnancy, interstitial pregnancy;
• The age of the patient \< 18 years or \> 41 years;
• Irregular menstruation or abnormal results of sex hormone tests during follow-up;
• Abnormal results of the man's semen examination during the follow-up period;
• The patient has a tendency to bleed easily;
• History of myometriosis and endometriosis;
• Abnormal blood routine examination or liver and kidney function;
• History of cardiovascular diseases, including severe hypertension, severe arrhythmias, history of myocardial infarction;
• History of hepatitis B or C infection and patient has a detectable viral load;
• Patients with active tuberculosis;
• History of malignant tumors;
• Unable to regularly monitor the follicles during pregnancy;
• Unconditional long-term follow-up;

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead
• Shanghai 7th People's Hospital: collaborator
• Shanghai Zhoupu Hospital: collaborator
• Shanghai Pudong Hospital: collaborator

Study Sites (1)

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

Related Publications (1)

• Mol F, van Mello NM, Strandell A, Strandell K, Jurkovic D, Ross J, Barnhart KT, Yalcinkaya TM, Verhoeve HR, Graziosi GCM, Koks CAM, Klinte I, Hogstrom L, Janssen ICAH, Kragt H, Hoek A, Trimbos-Kemper TCM, Broekmans FJM, Willemsen WNP, Ankum WM, Mol BW, van Wely M, van der Veen F, Hajenius PJ; European Surgery in Ectopic Pregnancy (ESEP) study group. Salpingotomy versus salpingectomy in women with tubal pregnancy (ESEP study): an open-label, multicentre, randomised controlled trial. Lancet. 2014 Apr 26;383(9927):1483-1489. doi: 10.1016/S0140-6736(14)60123-9. Epub 2014 Feb 3.

  PMID: 24499812 RESULT

MeSH Terms

Conditions

Pregnancy, Tubal

Condition Hierarchy (Ancestors)

Pregnancy, Ectopic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: January 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: December 31, 2023
• Last Updated: August 12, 2022

Record last verified: 2022-08

Locations

CN (1)